Pelvic Physical Therapy for Sexual Dysfunction

Overseen By Study Nurse

Age: 18+

Sex: Female

Trial Phase: Academic

Sponsor: Wake Forest University Health Sciences

Disqualifiers: Active infection, Vaginal fistula, Active cancer, others

Compensation: Varies

Number of Visits: 3

Duration: 10 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether pelvic physical therapy can improve sexual function and quality of life for survivors of gynecologic cancers, such as cervical or ovarian cancer. It compares a 10-week physical therapy program to receiving only educational materials. The trial aims to determine if the therapy is practical and effective for these survivors. Individuals who have completed cancer treatment, experience sexual dysfunction, and speak English might be suitable candidates. As an unphased trial, this study offers participants a unique opportunity to contribute to pioneering research that could enhance post-cancer care.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that pelvic physical therapy is safe for gynecologic cancer survivors?

Research shows that pelvic physical therapy is generally well-tolerated and may improve sexual function. Studies have found that pelvic floor muscle exercises, a key part of this therapy, significantly enhance sexual health for women. For instance, women reported better scores on tests measuring desire, arousal, and satisfaction.

Therapy programs that include biofeedback, a method that helps people control body processes, have high satisfaction rates. These treatments are considered safe, with few reports of side effects, making them a good option for those experiencing sexual issues after gynecologic cancer.

Overall, pelvic physical therapy appears to be a safe and promising way to improve sexual function and quality of life. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about pelvic physical therapy for sexual dysfunction in gynecologic oncology survivors because it offers a non-invasive, therapeutic approach that directly targets the pelvic floor muscles, which are often affected after cancer treatments. Unlike standard care options like medications or surgeries, which can have significant side effects or require long recovery times, pelvic physical therapy focuses on exercises and techniques to improve muscle function and blood flow, potentially enhancing sexual function and quality of life without additional medical risks. This method empowers patients by giving them active roles in their recovery, fostering a sense of control and personal improvement.

What evidence suggests that pelvic physical therapy is effective for sexual dysfunction in gynecologic cancer survivors?

Research shows that pelvic physical therapy, which participants in this trial may receive, can help improve sexual function in women. Studies indicate that exercises to strengthen the pelvic floor muscles can increase scores on the Female Sexual Function Index (FSFI), which measures various aspects of sexual health. In a review of several studies, women who received this therapy reported better overall sexual function. Additionally, physical therapy reduced pain and enhanced quality of life related to sexual health. These findings suggest that pelvic physical therapy could benefit gynecologic cancer survivors experiencing sexual difficulties. ^{1 2 6 7 8}

Who Is on the Research Team?

Suzanne Danhauer, PhD

Principal Investigator

Wake Forest Baptist Comprehensive Cancer Center

Anya Menzies, PhD

Principal Investigator

Wake Forest Baptist Comprehensive Cancer Center

Are You a Good Fit for This Trial?

Inclusion Criteria

History of cervical, ovarian/fallopian tube/primary peritoneal, uterine, or vulvar/vaginal cancer, regardless of stage or amount of prior therapy. Patients must have completed radiation therapy 12 weeks prior enrollment. Patients must be at least 12 weeks remote from surgery. There is no minimum time after completion of chemotherapy for enrollment. There is no upper limit of time from treatment.

Screen positive for sexual dysfunction based on answers to the Brief Sexual Symptom Checklist for Women. A patient screens positive if they answer 'no' to the first question (Are you satisfied with your sexual function?) and if they select any answer other than 'a' in the third question (Mark which of the following problems you are having). The other questions do not impact whether a patient screens positive or negative. They do not have an impact on study eligibility.

English-speaking. Due to the developmental nature of this study, assessing feasibility with a small number of patients, we do not have all response tools and questionnaires translated into multiple languages. In a future larger study, it will be important to translate all documents into multiple languages in order to include non-English speakers.

Exclusion Criteria

Active pelvic infection.

You have a hole between your vagina and another organ, which can cause health problems.

Deemed not suitable for pelvic physical therapy based on physician assessment. If there is suspicion for infection, disease recurrence, or other concerning medical findings that necessitate further evaluation and work up at that time.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo a 10-week pelvic physical therapy regimen to address sexual dysfunction

10 weeks

Weekly visits for physical therapy

Follow-up

Participants are monitored for sexual function and quality of life improvements

6 months

Assessments at 3 months and 6 months post-treatment

What Are the Treatments Tested in This Trial?

Interventions

• Pelvic Physical Therapy

How Is the Trial Designed?

Group I: Physical Therapy Arm Experimental Treatment 4 Interventions

Physical therapy for sexual dysfunction.

Group II: Control Arm Placebo Group 1 Intervention

Educational pamphlet with resources for sexual dysfunction

Who Is Running the Clinical Trial?

Wake Forest University Health Sciences

Lead Sponsor

Trials

1,432

Recruited

2,506,000+

Published Research Related to This Trial

Radiotherapy for gynecological cancers often leads to significant side effects in women, such as vaginal dryness, stenosis, and pain, affecting their sexual health, as analyzed in 19 studies involving 2,739 women.

While there is some evidence suggesting that pelvic floor muscle training (PFMT) may help manage sexual dysfunction after radiotherapy, the current studies are limited in quality and quantity, indicating a need for more rigorous research to confirm its effectiveness.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Sexual Health Dysfunction After Radiotherapy for Gynecological Cancer: Role of Physical Rehabilitation Including Pelvic Floor Muscle Training. Barcellini, A., Dominoni, M., Dal Mas, F., et al.[2022]

Pelvic physical therapy is an effective first-line treatment for various types of urinary incontinence, offering non-invasive symptom relief with low risk of side effects and moderate costs, making it suitable for a wide range of patients including women, men, children, and the elderly.

Specific interventions like pelvic floor muscle (PFM) training and electrical stimulation have been shown to improve outcomes, particularly after radical prostatectomy in men, by reducing incontinence duration and enhancing quality of life.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[The role of the pelvic physical therapist]. Berghmans, B.[2019]

A qualitative study involving 28 gynecological cancer survivors found that multimodal pelvic floor physical therapy (PFPT) is acceptable and beneficial for treating dyspareunia, with participants reporting significant improvements in their condition.

Despite some participants finding the treatment intensity demanding, overall satisfaction was high, and all participants recommended the therapy, highlighting its effectiveness and relevance in their recovery process.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Acceptability of multimodal pelvic floor physical therapy to treat dyspareunia after gynecological malignancies: a qualitative study of women's views and experiences. Cyr, MP., Dostie, R., Camden, C., et al.[2023]

In a study of 474 women undergoing pelvic floor physical therapy (PFPT), significant improvements were observed in validated symptom scores, particularly for pelvic pain, with median scores on the Pelvic Floor Distress Inventory (PFDI) dropping from 77.3 to 41.8 after treatment (P < 0.0001).

Women with pelvic pain showed notable enhancements in their quality of life and pain levels, meeting the minimal clinically important difference for multiple measures, indicating that PFPT is an effective intervention for alleviating pelvic floor symptoms.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Symptom and Quality of Life Improvements After Pelvic Floor Physical Therapy in a Clinical Population of Women With Pelvic Pain and Other Symptoms. Killinger, KA., Henrichsen, JL., Han, E., et al.[2021]

A survey of 53 physical therapists in a rural healthcare setting revealed that 58% received less than 2 hours of training in pelvic floor physical therapy (PFPT) during their graduate education, indicating a significant gap in initial training.

Despite the low training levels, 95% of therapists pursued additional post-graduate training in PFPT, suggesting a strong commitment to improving their skills to better serve patients with pelvic floor dysfunction.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Training of Physical Therapists in Pelvic Floor Techniques: Is Care Available in the Rural Midwest? Biach, V., van Oosbree, A., Cookson, N., et al.[2023]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8550487/

Effectiveness of Physical Therapy in Addressing Sexual ... Outcomes included pelvic floor muscle function and the FSFI score. After the intervention, all three groups demonstrated statistically significant improvements ...

2. nature.com nature.com/articles/s41443-025-01034-5

Pelvic physical therapy for male sexual disorders Research supporting the effectiveness of PPT in men with sexual dysfunction shows improvements in erectile function, ejaculatory control, and ...

3. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/38191016/

Pelvic floor muscle training as treatment for female sexual ... This systematic review and meta-analysis showed that pelvic floor muscle training improved female Female Sexual Function Index total score and several ...

4. bmcwomenshealth.biomedcentral.com bmcwomenshealth.biomedcentral.com/articles/10.1186/s12905-023-02532-8

Effectiveness of physical therapy interventions in women with ... These interventions did not show significant results for the improvement of sexual function. Conclusions. Physiotherapy techniques are effective ...

5. ics.org ics.org/2024/abstract/227

The effects of physiotherapy interventions in the treatment ... The study that used lidocaine found that physiotherapy was more effective in reducing pain, improving sexual function, and qualitative pain ...

6. bmcwomenshealth.biomedcentral.com bmcwomenshealth.biomedcentral.com/articles/10.1186/s12905-024-03475-4

Clinical outcomes of a digital musculoskeletal women's pelvic ... Pain catastrophizing, poor general health, low quality of life, and sexual dysfunction are often comorbid in women with CPP [4,5,6,7]. Headaches ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC5323296/

Prospective Outcomes of a Pelvic Floor Rehabilitation ... An aggressive pelvic rehabilitation program including biofeedback with vaginal EGS had a high rate of self-reported subjective success and satisfaction.

8. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0002937824000061

Pelvic floor muscle training as treatment for female sexual ... This systematic review and meta-analysis showed that pelvic floor muscle training improved female Female Sexual Function Index total score and several subscales ...